WO1983000158A1 - Clear, autoclavable thermoplastic formulation for medical liquid containers - Google Patents
Clear, autoclavable thermoplastic formulation for medical liquid containers Download PDFInfo
- Publication number
- WO1983000158A1 WO1983000158A1 PCT/US1982/000473 US8200473W WO8300158A1 WO 1983000158 A1 WO1983000158 A1 WO 1983000158A1 US 8200473 W US8200473 W US 8200473W WO 8300158 A1 WO8300158 A1 WO 8300158A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- weight
- thermoplastic
- ethylene
- block
- polymer
- Prior art date
Links
Classifications
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
- C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
- C08L23/10—Homopolymers or copolymers of propene
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/04—Heat
- A61L2/06—Hot gas
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/26—Accessories or devices or components used for biocidal treatment
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
- C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
- C08L23/10—Homopolymers or copolymers of propene
- C08L23/12—Polypropene
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L2205/00—Polymer mixtures characterised by other features
- C08L2205/03—Polymer mixtures characterised by other features containing three or more polymers in a blend
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
- C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
- C08L23/04—Homopolymers or copolymers of ethene
- C08L23/08—Copolymers of ethene
- C08L23/0846—Copolymers of ethene with unsaturated hydrocarbons containing other atoms than carbon or hydrogen atoms
- C08L23/0869—Acids or derivatives thereof
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L53/00—Compositions of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L53/00—Compositions of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers
- C08L53/02—Compositions of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers of vinyl-aromatic monomers and conjugated dienes
Definitions
- the present application relates generally to medical plastic formulations and particularly to medical liquid containers such as flexible, collapsible, intra venous solution containers.
- the materials disclosed exhibit the particular advantages of being essentially transparent, soft and flexible, essentially free of extractables, and able to resist high temperatures present in autoclaving.
- Various materials have been utilized for intravenous solution containers in the past.
- U.S. Patent No. 4,140,162 discloses a formulation for medical liquid containers containing both polypropylene and a block copolymer.
- a third ingredient disclosed comprises polyethylene or polyethylene vinyl acetate.
- the present invention is distinguished from the '162 patent by the use of ethylene methyl acrylate, which is lower in cost and provides more desirable physical properties such as improved thermal stability and a wider range of processing temperatures.
- Other formulations of block copolymers which include polypropylene may be found in U.S. Patent No. 3,792,124. These formulations are not suitable for flexible medical liquid containers, however, in that they are ionic,
- a clear, flexible, thermoplastic material capable of being processed into hollow shapes by conventional plas tic processing methods and subsequently autoclaved.
- the material comprises: (A) from about 40 to 70% by weight of a polyolefin, usually polypropylene a ⁇ ir.ixed with (B) from about 5 to 40% by weight of an ethylene loweralkyl acrylate; and (C) from about 5 to 40% by weight of one of several block copolymers: ethylene butylene having terminal polystyrene units, butadiene styrene having terminal polystyrene units, an olefin elastomer of the ethylene propylene type, or butyl rubber (polybutadiene isoprene).
- Ingredient (A) as described above is a polyolefin consisting essentially of polypropylene units. Many commercial varieties of polypropylene contain small amounts of ethylene units. This does not make a major impact on the properties of the propylene material.
- Ingredient (B) generally comprises ethylene methyl acrylate (EMA) and is commercially available from Gulf Oil Chemicals Co., Orange, Texas, under the numbers 2205 and 2255.
- EMA is a random copolymer consisting of a polyethylene backbone with methyl acrylate side branches. Gulf's present commercial product contains approximately 20% by weight of methyl acrylate.
- EMA's distinguishing properties include a low melt temperature and corresponding easy heat sealability, as well as good thermal stability in the range of 600 to 630° F., and "rubbery" mechanical properties, including low stiffness, high elongation, clarity and high impact strength.
- Table I A comparison of ethylene methyl acrylate to ethylene vinyl acetate may be seen in the following Table I:
- EMA EMA's great thersal stability. EMA can be processed at very high temperatures; up to 600 to 630°F. without polymer breakdown anc/or chain cission. Some of the other low density polyethylene copolymers, like EVA, when mixed with high temperature- resistant plastics such as polypropylene and high density polyethylene and heated in excess of 450°F. begin to break down and liberate acids that attack netal surfaces of extrusion equipment.
- Loweralkyl ethylene acrylates may be utilized such as ethylene ethyl acrylate and ethylene butyl acrylate, with similar results.
- Loweralkyl is defined as an alkyl group having 1-5 carbon atoms, such as ethyl, methyl, butyl, etc.
- the third element (C) of this novel plastic material comprises from about 5 to 40% by weight of a thermoplastic composition; usually a block copolymer of ethylene butylene having terminal polystyrene units.
- Ethylene butylene block copolymers having terminal polystyrene units are commercially available under the trademark Kraton G® from the Shell Chemical Co.
- Other rubbery block copolymers such as butadiene styrene having terminal polystyrene units may also be utilized.
- the impermeable polymeric compositions disclosed in U.S. Patent 3,686,364 assigned to Polymer Corporation Limited hereby incorporated by reference, discloses a series of butadiene styrene block copolymers useful as the third element in the present application.
- ethylene propylene dienemonomer elastomer available from Heisler Corporation under the number HC-5214, may also be used as the third ingredient of the material.
- Table III discloses a series of examples of the above listed material, showing in particu lar, the proportionate percentages, by weight, of element A, B and C.
- 10% ethylene methyl acrylate was mixed with 90% polypropylene.
- the resulting combination was then mixed in a proportion of 70% EMA polypropylene to 30% element C.
- the resulting material exhibited the following properties, as seen in Table IV.
- the resulting formulation was found to be highly suitable for sheet extrusion, injection molding or blow molding into flexible, transparent, autoclavable intravenous solution containers.
- the resulting container was found to be of sufficient strength to withstand heavy impact during shipment and use, while at the same time being sufficiently flexible to collapse easily during drainage of intravenous solution from the container.
- a block copolymer having thermoplastic rubber characteristics consisting essentially of a rubbery olefin polymer of generally equal proportions of ethylen and butylene units in terminal blocks of polystyrene was added to a rotational mixer in the amount of 40% by weight with 10% by weight of a blend of 90% polypropylen and 10% EMA.
- the block copolymer used was Kraton 2705 sold by the Shell Chemical Company. Mechanical proper ties of Kraton 2705 are as follows:
- the ingredients were premixed in the rotational mixer and then introduced into an extruder for extrusion into a rod.
- the rods were then chopped into smaller pellet sized pieces.
- the chopped pellets were utilized in the commercially available blow molding apparatus, specifically a continuous extrusion machine, with a secondary blow station manufactured by Romellog Fellbach of Oeffingen.
- the material was found to be successfully fabricated into a transparent, flexible, collapsible intravenous solution container which was autoclavable under a typical sterilizing cycle without an distortion.
- each polymer block A being selected from the group consisting of monoalkenyl arine polymers and hydrogenated products thereof wherein no more than 25% of the arine double bonds had been reduced and polymer block B is a hydrogenated polymer block of a C 4 -5 conjugated diene polymer wherein at least about 30% of the aliphatic unsaturation has been reduced by hydrogenation.
- each polystyrene block has an average molecular weight between about 2,000 and 50,000 and the hydrogenated polybutadiene block has an average molecular weight between about 20,000 and 300,000.
- alpha-beta-alpha block copolymer (hereinafter referred to as alpha-beta-alpha block copolymer) was prepared and blended with uncured butyl rubber.
- the alpha-beta-alpha block copolymer had an alpha methyl styrene content of approximately 35% weight and a molecular weight of about 60,000.
- Three separate blends were prepared using 30, 40 and 50 parts by weight of butyl rubber respectively with 100 parts by weight of alpha-beta-alpha block copolymer. The blending was carried out on a ⁇ iicromil, the mil rolls were at elevated temperatures in the range of about 130°C. to about 150°C. The resulting blends were then admixed with components A and B as previously described.
- Element C comprises 10% by weight of a thermoplastic composition comprising a block copolymer having at least two monoalkenyl arine polymer blocks and at least one substantially completely hydrogenated diene polymer block.
- polymer block A is a block copolymer having the structure polystyrene-completely hydrogenated polybutadiene-polystyrene with block molecular weights of 25,000-100,000-25,000.
- An alternative formulation is a block copolymer of the same structure and block identity but having block molecular weights of 10,000-50,000- 10,000.
- a block copolymer of general form polyethyl methyl styrene polybutadiene polyethyl methyl styrene was prepared with different quantities of uncured butyl rubber.
- the alpha-beta-alpha block copolymer had an alpha methyl styrene content of approximately 35 percent by weight and a molecular weight of about 60,000.
- the nonterminal elastomer block may be polybutadiene, or polybutadiene and butyl rubber.
- the resulting block copolymer was then admixed with components A and B.
- nucleating agent such as sodium benzoate or millad 3900 polyolefin clarifies both manufactured by Miniiken Corp., nay be added to the above listed formulations to improve clarity.
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicinal Chemistry (AREA)
- Polymers & Plastics (AREA)
- Organic Chemistry (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Compositions Of Macromolecular Compounds (AREA)
Abstract
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
BR8207774A BR8207774A (en) | 1981-06-29 | 1982-04-15 | TRANSPARENT AUTOCLAVAVEL THERMOPLASTIC FORMULATION FOR MEDICINE LIQUID CONTAINER |
AU85219/82A AU8521982A (en) | 1981-06-29 | 1982-04-15 | Clear, autoclavable thermoplastic formulation for medical liquid containers |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US27825381A | 1981-06-29 | 1981-06-29 | |
US278,253810629 | 1981-06-29 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1983000158A1 true WO1983000158A1 (en) | 1983-01-20 |
Family
ID=23064285
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1982/000473 WO1983000158A1 (en) | 1981-06-29 | 1982-04-15 | Clear, autoclavable thermoplastic formulation for medical liquid containers |
Country Status (9)
Country | Link |
---|---|
EP (1) | EP0082154A1 (en) |
JP (1) | JPS58501035A (en) |
BR (1) | BR8207774A (en) |
CA (1) | CA1191985A (en) |
ES (1) | ES513453A0 (en) |
IT (1) | IT1153547B (en) |
PH (1) | PH18514A (en) |
WO (1) | WO1983000158A1 (en) |
ZA (1) | ZA823100B (en) |
Cited By (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE3337997A1 (en) * | 1982-10-21 | 1984-04-26 | Dainippon Plastics Co., Ltd., Osaka | RESIN COMPOSITION |
EP0164190A2 (en) * | 1984-04-05 | 1985-12-11 | Exxon Research And Engineering Company | Sterilizable packages and processes |
EP0184296A2 (en) * | 1984-11-08 | 1986-06-11 | Mobil Oil Corporation | Blends of polypropylene, polycarbonate and a saturated styrene-ethylene-butylene-styrene rubber |
EP0308001A2 (en) * | 1987-09-04 | 1989-03-22 | Shell Internationale Researchmaatschappij B.V. | Polymeric composition |
EP0330151A2 (en) * | 1988-02-23 | 1989-08-30 | Nissho Corporation | Bag for the storage of blood platelets |
WO1995014739A2 (en) * | 1993-11-16 | 1995-06-01 | Baxter International Inc. | Polymeric compositions for medical packaging and devices |
EP0832930A1 (en) * | 1996-09-26 | 1998-04-01 | Shell Internationale Researchmaatschappij B.V. | Thermoplastic elastomer composition with improved overmolding adhesion |
US6183460B1 (en) | 1998-01-22 | 2001-02-06 | Baxter International Inc. | Multi-use solution container having flaps |
WO2007024957A1 (en) * | 2005-08-26 | 2007-03-01 | Becton, Dickinson And Company | Methods of sterilizing elastomeric sealing articles |
EP2151478A1 (en) * | 2007-05-25 | 2010-02-10 | Kuraray Co., Ltd. | Thermoplastic polymer composition |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3361852A (en) * | 1965-09-15 | 1968-01-02 | Union Carbide Corp | Ternary polypropylene compositions containing ethylene/propylene and ethylene/vinyl ester copolymers |
US4107130A (en) * | 1976-06-07 | 1978-08-15 | Shell Oil Company | Multicomponent polyolefin-block copolymer-polymer blends |
US4277578A (en) * | 1977-10-11 | 1981-07-07 | Asahi-Dow Limited | Composition for drawn film, cold drawn film made of said composition and process for manufacture of said film |
-
1982
- 1982-04-15 BR BR8207774A patent/BR8207774A/en unknown
- 1982-04-15 JP JP57501697A patent/JPS58501035A/en active Pending
- 1982-04-15 WO PCT/US1982/000473 patent/WO1983000158A1/en not_active Application Discontinuation
- 1982-04-15 EP EP82901673A patent/EP0082154A1/en not_active Withdrawn
- 1982-04-22 CA CA000401489A patent/CA1191985A/en not_active Expired
- 1982-04-26 PH PH27191A patent/PH18514A/en unknown
- 1982-05-05 ZA ZA823100A patent/ZA823100B/en unknown
- 1982-06-25 ES ES513453A patent/ES513453A0/en active Granted
- 1982-06-28 IT IT22101/82A patent/IT1153547B/en active
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3361852A (en) * | 1965-09-15 | 1968-01-02 | Union Carbide Corp | Ternary polypropylene compositions containing ethylene/propylene and ethylene/vinyl ester copolymers |
US4107130A (en) * | 1976-06-07 | 1978-08-15 | Shell Oil Company | Multicomponent polyolefin-block copolymer-polymer blends |
US4277578A (en) * | 1977-10-11 | 1981-07-07 | Asahi-Dow Limited | Composition for drawn film, cold drawn film made of said composition and process for manufacture of said film |
Cited By (24)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE3337997A1 (en) * | 1982-10-21 | 1984-04-26 | Dainippon Plastics Co., Ltd., Osaka | RESIN COMPOSITION |
EP0164190A2 (en) * | 1984-04-05 | 1985-12-11 | Exxon Research And Engineering Company | Sterilizable packages and processes |
EP0164190A3 (en) * | 1984-04-05 | 1986-10-22 | Exxon Research And Engineering Company | Sterilizable packages and processes |
EP0184296A2 (en) * | 1984-11-08 | 1986-06-11 | Mobil Oil Corporation | Blends of polypropylene, polycarbonate and a saturated styrene-ethylene-butylene-styrene rubber |
EP0184296A3 (en) * | 1984-11-08 | 1989-05-17 | Mobil Oil Corporation | Blends of polypropylene, polycarbonate and a saturated styrene-ethylene-butylene-styrene rubber |
EP0308001A3 (en) * | 1987-09-04 | 1990-09-12 | Shell Internationale Research Maatschappij B.V. | Polymeric composition |
EP0308001A2 (en) * | 1987-09-04 | 1989-03-22 | Shell Internationale Researchmaatschappij B.V. | Polymeric composition |
EP0330151A2 (en) * | 1988-02-23 | 1989-08-30 | Nissho Corporation | Bag for the storage of blood platelets |
EP0330151A3 (en) * | 1988-02-23 | 1991-07-03 | Nissho Corporation | Bag for the storage of blood platelets |
WO1995014739A2 (en) * | 1993-11-16 | 1995-06-01 | Baxter International Inc. | Polymeric compositions for medical packaging and devices |
WO1995014739A3 (en) * | 1993-11-16 | 1995-08-24 | Baxter Int | Polymeric compositions for medical packaging and devices |
AU686697B2 (en) * | 1993-11-16 | 1998-02-12 | Baxter International Inc. | Polymeric compositions for medical packaging and devices |
CN1066757C (en) * | 1993-11-16 | 2001-06-06 | 巴克斯特国际有限公司 | Polymeric compositions for medical packaging and devices |
EP1008357A2 (en) * | 1993-11-16 | 2000-06-14 | Baxter International Inc. | Polymeric compositions for medical packaging and devices |
EP1008357A3 (en) * | 1993-11-16 | 2000-07-26 | Baxter International Inc. | Polymeric compositions for medical packaging and devices |
EP0832930A1 (en) * | 1996-09-26 | 1998-04-01 | Shell Internationale Researchmaatschappij B.V. | Thermoplastic elastomer composition with improved overmolding adhesion |
KR100515873B1 (en) * | 1996-09-26 | 2006-01-12 | 셀 인터나쵸나아레 레사아치 마아츠샤피 비이부이 | Thermoplastic elastomer composition with improved overmolding adhesion |
US6183460B1 (en) | 1998-01-22 | 2001-02-06 | Baxter International Inc. | Multi-use solution container having flaps |
WO2007024957A1 (en) * | 2005-08-26 | 2007-03-01 | Becton, Dickinson And Company | Methods of sterilizing elastomeric sealing articles |
US7758806B2 (en) | 2005-08-26 | 2010-07-20 | Becton, Dickinson And Company | Methods of sterilizing elastomeric sealing articles |
EP2151478A1 (en) * | 2007-05-25 | 2010-02-10 | Kuraray Co., Ltd. | Thermoplastic polymer composition |
EP2151478A4 (en) * | 2007-05-25 | 2010-06-23 | Kuraray Co | Thermoplastic polymer composition |
US8933174B2 (en) | 2007-05-25 | 2015-01-13 | Kurarary Co., Ltd. | Thermoplastic polymer composition |
KR101506047B1 (en) * | 2007-05-25 | 2015-03-25 | 가부시키가이샤 구라레 | Thermoplastic polymer composition |
Also Published As
Publication number | Publication date |
---|---|
IT1153547B (en) | 1987-01-14 |
EP0082154A1 (en) | 1983-06-29 |
JPS58501035A (en) | 1983-06-30 |
PH18514A (en) | 1985-08-02 |
BR8207774A (en) | 1983-05-31 |
ES8403500A1 (en) | 1983-08-16 |
IT8222101A0 (en) | 1982-06-28 |
ES513453A0 (en) | 1983-08-16 |
ZA823100B (en) | 1983-03-30 |
CA1191985A (en) | 1985-08-13 |
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